MRI NCD Being Reconsidered, Again
Your Medicare patients with pacemakers and defibrillators may be able to have magnetic studies in the very near future, providing data proves supportive.
New technology has led the Centers for Medicare & Medicaid Services (CMS) to take another look at its recently updated national coverage determination (NCD) for magnetic resonance imaging (MRI). Section 220.2 of the NCD Manual establishes MRI coverage for a number of uses. Aside from an exception for MRI furnished in approved clinical studies of implanted pacemakers and implantable cardioverter defibrillators (ICDs) under the Coverage with Evidence Development (CED) paradigm, however, MRI remains noncovered when certain patient-specific contraindications are present, including patients who have implanted cardiac pacemakers. But a new device said to be the first pacemaker for use in an MRI environment has led CMS to reconsider, again, its MRI NCD.
The U.S. Food and Drug Administration (FDA) approval of the Medtronic Revo MRI™ SureScan® pacing system came just days after the close of public comment period for the recent reconsideration of the MRI NCD (CAG-00399R2, published Feb. 24). Consequently, CMS didn’t have enough time to review the evidence and issue a final decision regarding the device before the statutory due date.
The purpose of this new national coverage analysis (NCA) is to determine the conditions under which MRI for patients with implanted devices, when furnished fully within FDA approved labeling for use in an MRI environment, including post approval study requirements, may be reasonable and necessary.
The FDA approved labeling for Medtronic’s pacing system is MR-Conditional. In other words, the device is recommended for use in an MRI environment under certain conditions, such as a particular type of MRI scanner and scanner settings.
This reconsideration is limited to MRI and does not include any coverage determination about the Medtronic Revo MRI™ SureScan® pacing system itself or any other pacemaker. CMS says it is particularly interested in receiving comment on coverage in the context of FDA post approval requirements for the Medtronic Revo MRI™ SureScan® pacing system.
The NCA for MRI report (CAG-00399R3), posted March 3, is available on the CMS Medicare Coverage Database website. See Pub. 100-03, NCD Manual, section 220.2, for the MRI coverage policy, and Pub. 100-04, Claims Processing Manual, chapter 13, section 40.1, for claims processing instructions.